10-Q · May 12, 2026
Achieve Life Sciences reported a net loss of $10.2 million for Q1 2026 and a diluted EPS of -$0.28, missing estimates by 3.7%. The company continues its focus on advancing cytisinicline for smoking cessation, with…
Earnings analysis · 10-Q
ACHV earnings analysis
Filed August 11, 2026 · Our reading of the company's report
The latest report
Achieve remains a pre-commercial biotechnology company with no product-sale revenue and reported diluted EPS of negative $0.80 for the quarter, materially below the negative $0.16 estimate provided in the earnings data.…
Read full summary
Achieve remains a pre-commercial biotechnology company with no product-sale revenue and reported diluted EPS of negative $0.80 for the quarter, materially below the negative $0.16 estimate provided in the earnings data. The June 2026 FDA Complete Response Letter, involving 2 manufacturing observations and unfinished labeling, delays the regulatory path, although management has advanced the Adare manufacturing transition and targets NDA resubmission in the fourth quarter of 2026 with potential approval in the first half of 2027. Liquidity and execution remain key concerns given $15.0 million of debt, no operating cash flow, substantial potential dilution, and the new Sopharma arbitration.
How we read each report
Our analysis across the last few reports.
Our model's reading of each filing, not the share price or the market's reaction. Annual and quarterly reports each occupy one position.
Reported figures
- Earnings per share
- $-0.8
What stood out
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Adare manufacturing transition advanced
Management completed analytical method transfer to Adare, completed the first cytisinicline engineering batch at Adare’s facility, and fully qualified all testing procedures at the site.
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Long-term safety package progressed
The long-term ORCA-OL safety trial enrolled 479 subjects at 29 U.S. sites; the NDA included data from more than 300 participants with at least six months of cumulative exposure and more than 100 participants with at least one year of exposure.
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Broad clinical evidence base
Cytisinicline’s clinical program included two Phase 3 trials randomizing a total of 1,602 adult smokers across 37 U.S. sites, plus a Phase 2 vaping-cessation trial involving 160 adults.
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Debt maturity is clearly defined
The company reported $15.0 million of principal debt outstanding as of June 30, 2026, with debt maturing on June 1, 2028, providing a defined debt maturity but ongoing financing obligations.
What to watch
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FDA CRL delays approval timeline
The FDA issued a Complete Response Letter in June 2026 citing manufacturing-related observations at a prior third-party facility, including 2 observations related to solid oral dose manufacturing, as well as incomplete final product labeling.
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Sopharma arbitration creates supply risk
Sopharma filed an arbitration demand on July 17, 2026 seeking damages, fees, restitution, declaratory relief, and an order requiring inclusion as the designated manufacturer in future NDA submissions. The dispute could delay or restrict commercialization of cytisinicline.
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New manufacturer transition remains risky
The company is transitioning finished-drug manufacturing to Adare and warns of technical challenges, failed batches, release-testing delays, capacity constraints, and regulatory findings. Adare’s Chief Executive Officer also serves on Achieve’s Board of Directors, creating a potential conflict-of-interest risk.
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Potential dilution remains substantial
As of June 30, 2026, approximately 69,909,876 shares were subject to outstanding warrants with a weighted-average exercise price of $3.45, in addition to 9,299,447 shares subject to options and 14,479,065 shares subject to restricted stock units.
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Operating cash deficit and secured debt
The company states that it currently generates no cash flow from operations and had $15.0 million of principal debt outstanding as of June 30, 2026; failure to service the secured debt could result in default or foreclosure on substantially all assets other than intellectual property.
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No product revenue or diversified pipeline
The company has never generated revenue from product sales and does not anticipate generating product-sale revenue for the foreseeable future, leaving it dependent on additional financing and successful FDA approval of its sole product candidate.
Management's outlook
No quantitative revenue or EPS guidance was provided. Management intends to resubmit the cytisinicline NDA naming Adare as finished drug product manufacturer in the fourth quarter of 2026 and anticipates potential FDA approval in the first half of 2027, followed by a U.S. commercial launch.
Earlier filings 4
10-K · April 30, 2026
Achieve Life Sciences, Inc. reported an unresolved performance in fiscal year 2025, closing with zero revenue and a diluted EPS of -0.26. During the year, the company initiated significant financing and leadership…
10-K · March 24, 2026
Achieve Life Sciences is a late-stage specialty pharma company focused solely on cytisinicline for smoking and e‑cigarette cessation. The 10‑K highlights meaningful regulatory progress (NDA accepted with a PDUFA date,…
10-K · March 11, 2025
Achieve Life Sciences is a late-stage specialty pharma focused solely on cytisinicline for smoking and e‑cigarette cessation; the company expects to file an NDA at the end of Q2 2025 and has completed enrollment in its…
This is our reading of a public filing, not the filing itself. Analysis can contain errors; check the source document for full context.